Job Description

Production Associate – Documentation & Administration

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Specialty Probiotics Australia – Ormeau QLD

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The Production Associate – Documentation & Administration is responsible for preparing, administering and controlling production documentation to ensure manufacturing records are accurate, current, traceable and compliant with TGA, PIC/S GMP, GDP and company QMS requirements.

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Key Responsibilities

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- Draft and maintain BMRs, BPRs, manufacturing instructions, worksheets, checklists and production forms.
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- Ensure current approved documents are issued and obsolete versions controlled.
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- Maintain production records, registers, batch status and ERP/MRP information.
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- Prepare production reports covering output, yield, waste, downtime and schedule performance.
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- Conduct initial administrative checks of completed batch records for completeness, signatures, calculations and reconciliations.
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- Identify and elevate documentation errors, discrepancies and data-integrity concerns.
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- Maintain production records in an audit-ready condition.
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- Support deviations, investigations, CAPA and approved Change Controls.
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- Retrieve production documentation for TGA and GMP audits.
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- Identify opportunities to improve production documentation and administration.
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KPIs

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- Accurate and timely preparation and issue of production documents.
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- Completed BMRs/BPRs submitted within agreed timelines.
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- High GMP/GDP compliance and minimal documentation errors.
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- Accurate production reporting and record-keeping.
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- Production documentation maintained audit-ready.
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Authority

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Responsible for the accuracy and administration of production documentation.

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May draft, prepare and maintain production documents and recommend improvements.

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May not independently approve specifications, GMP-critical documents, process changes, deviations, CAPAs or finished product release.

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Experience & Competencies

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- Production administration or manufacturing documentation experience.
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- Excellent attention to detail and organisational skills.
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- Solid Microsoft Word and Excel capability.
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- Experience in GMP-regulated manufacturing highly desirable.
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- Knowledge of BMR/BPR preparation and TGA/PIC/S GMP desirable.
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- Strong written communication and ability to manage deadlines.
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Training

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GMP/PIC/S, TGA requirements, GDP/Data Integrity, QMS, Document Control, BMR/BPR, SOPs, Deviation/CAPA, Change Control and WHS.

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Work Environment

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The role is expected to start at 7:00am and finish at 3:00pm

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The role is site-based and expected to be completed at the office and in the GMP facility based in Ormeau.

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📌 Production Associate - Documentation & Administration (City of Gold Coast)
🏢 Specialty Probiotics Australia
📍 City of Gold Coast